ASTM F629-15

Standard Practice for Radiography of Cast Metallic Surgical Implants

SIGNIFICANCE AND USE
4.1 The requirements in this practice are intended to control the quality of the radiographic image of cast metallic surgical implants and related weldments.
SCOPE
1.1 This practice covers the procedure for radiographic testing of cast metallic surgical implants and related weldments.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 30-Nov-2015
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaces: ASTM F629-11 - Standard Practice for Radiography of Cast Metallic Surgical Implants
• Effective Date: 01-Dec-2015
• Replaced By: ASTM F629-20 - Standard Practice for Radiography of Cast Metallic Surgical Implants
• Effective Date: 01-Feb-2020
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 01-Dec-2015
• Referred By: ASTM F3055-14a(2021) - Standard Specification for Additive Manufacturing Nickel Alloy (UNS N07718) with Powder Bed Fusion
• Effective Date: 01-Dec-2015
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 01-Dec-2015
• Referred By: ASTM F3056-14(2021) - Standard Specification for Additive Manufacturing Nickel Alloy (UNS N06625) with Powder Bed Fusion
• Effective Date: 01-Dec-2015
• Referred By: ASTM F2924-14(2021) - Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
• Effective Date: 01-Dec-2015
• Referred By: ASTM F2989-21 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
• Effective Date: 01-Dec-2015
• Referred By: ASTM F1108-21 - Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
• Effective Date: 01-Dec-2015
• Referred By: ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
• Effective Date: 01-Dec-2015
• Referred By: ASTM F2895-20 - Standard Practice for Digital Radiography of Cast Metallic Implants
• Effective Date: 01-Dec-2015
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 01-Dec-2015
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 01-Dec-2015
• Referred By: ASTM F2885-17(2023) - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
• Effective Date: 01-Dec-2015
• Referred By: ASTM F75-23 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
• Effective Date: 01-Dec-2015

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F629 − 15
Standard Practice for
1
Radiography of Cast Metallic Surgical Implants
ThisstandardisissuedunderthefixeddesignationF629;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
4
1. Scope* 2.3 AIA/NAS Standard:
NAS410 Certification and Qualification of Nondestructive
1.1 This practice covers the procedure for radiographic
Test Personnel
testing of cast metallic surgical implants and related weld-
5
2.4 CEN Standard:
ments.
EN 4179 Aerospace series – Qualification and approval of
1.2 The values stated in inch-pound units are to be regarded
personnel for non-destructive testing
as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only 3. Terminology
and are not considered standard.
3.1 For definitions used in this practice, refer to the terms in
1.3 This standard does not purport to address all of the
Test Method E1030 and Reference Radiographs E192.
safety concerns, if any, associated with its use. It is the
4. Significance and Use
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
4.1 The requirements in this practice are intended to control
bility of regulatory limitations prior to use.
the quality of the radiographic image of cast metallic surgical
implants and related weldments.
2. Referenced Documents
2
5. Radiographic Methods
2.1 ASTM Standards:
E94 Guide for Radiographic Examination 5.1 The radiographic method shall be agreed upon between
E192 Reference Radiographs of Investment Steel Castings
the purchaser and supplier but should be in accordance with
for Aerospace Applications Test Method E1030 and Guide E94.
E1030 Practice for Radiographic Examination of Metallic
5.1.1 Acceptance criteria should be derived from the refer-
Castings ence radiographs presented in Reference Radiographs E192,
E1320 Reference Radiographs for Titanium Castings
E1320, or digital reference images E2660 and E2669.
E2660 Digital Reference Images for Investment Steel Cast- 5.1.2 Digital radiography when agreed upon between pur-
ings for Aerospace Applications
chaser and supplier shall be performed in accordance with
E2669 Digital Reference Images for Titanium Castings Practice F2895.
F2895 Practice for Digital Radiography of Cast Metallic
5.2 Radiography of cobalt- or iron-base surgical implant
Implants
castings may create radiographic images resulting from grain
3
2.2 ASNT Standard:
diffraction. Radiographic techniques shall be utilized to ensure
SNT-TC-1A Recommended Practice for Personnel Qualifi-
differentiation between these images and actual indications.
cation and Certification in Nondestructive Testing
5.2.1 Generally, cobalt- or iron-base surgical implant cast-
ings require radiation intensities higher than normal, facilitat-
ing reduced exposure times.
5.2.1.1 Energies between 250 and 400 kV may be required
1
1 to radiograph surgical implants with a ⁄2-in. (12.7-mm) mate-
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
rial thickness.
F04.12 on Metallurgical Materials.
5.2.2 In some instances, filters, at the tube head, and
Current edition approved Dec. 1, 2015. Published February 2016. Originally
relatively thick lead intensifying screens may reduce grain
approved in 1979. Last previous edition approved in 2011 as F629 – 11. DOI:
diffraction while sustaining adequate radiographic sensitivity.
10.1520/F0629-15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
4
Standards volume information, refer to the standard’s Document Summary page on Available from Aerospace Industries Association (AIA), 1000 Wilson Blvd.,
the ASTM website. Suite 1700, Arlington, VA 22209, http://www.aia-aerospace.org.
3 5
AvailablefromAmericanSocietyforNondestructiveTesting(ASNT),P.O.Box Available from European Committee for Standardization (CEN), Avenue
28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http://www.asnt.org. Marnix 17, B-1000, Brussels, Belgium, http://www.cen.eu.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F629 − 15
5.2.3 Multiple radiographic exposures in which the implant 7.1.2 The mutually agreed upon acceptance or rejection
is rotated between 5 and 180°, relative to the film or detect
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F629 − 11 F629 − 15
Standard Practice for
1
Radiography of Cast Metallic Surgical Implants
This standard is issued under the fixed designation F629; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Scope*
1.1 This practice covers the procedure for radiographic testing of cast metallic surgical implants and related weldments.
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E94 Guide for Radiographic Examination
E192 Reference Radiographs of Investment Steel Castings for Aerospace Applications
E1030 Practice for Radiographic Examination of Metallic Castings
E1320 Reference Radiographs for Titanium Castings
E2660 Digital Reference Images for Investment Steel Castings for Aerospace Applications
E2669 Digital Reference Images for Titanium Castings
F2895 Practice for Digital Radiography of Cast Metallic Implants
3
2.2 ASNT Standard:
SNT-TC-1A Recommended Practice for Personnel Qualification and Certification in Nondestructive Testing
4
2.3 AIA/NAS Standard:
NAS410 Certification and Qualification of Nondestructive Test Personnel
5
2.4 CEN Standard:
EN 4179 Aerospace series – Qualification and approval of personnel for non-destructive testing
3. Terminology
3.1 For definitions used in this practice, refer to the terms in Test Method E1030 and Reference Radiographs E192.
4. Significance and Use
4.1 The requirements in this practice are intended to control the quality of the radiographic image of cast metallic surgical
implants and related weldments.
5. Radiographic Methods
5.1 The radiographic method shall be agreed upon between the purchaser and supplier but should be in accordance with Test
Method E1030 and Guide E94.
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.12
on Metallurgical Materials.
Current edition approved Dec. 1, 2011Dec. 1, 2015. Published December 2011February 2016. Originally approved in 1979. Last previous edition approved in 20072011
ε1
as F629 – 02 (2007)F629 – 11. . DOI: 10.1520/F0629-11.10.1520/F0629-15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American Society for Nondestructive Testing (ASNT), P.O. Box 28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http://www.asnt.org.
4
Available from Aerospace Industries Association (AIA), 1000 Wilson Blvd., Suite 1700, Arlington, VA 22209, http://www.aia-aerospace.org.
5
Available from European Committee for Standardization (CEN), Avenue Marnix 17, B-1000, Brussels, Belgium, http://www.cen.eu.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F629 − 15
5.1.1 Acceptance criteria should be derived from the reference radiographs presented in Reference Radiographs E192, E1320,
or digital reference images E2660 and E2669.
5.1.2 Digital radiography when agreed upon between purchaser and supplier shall be performed in accordance with Practice
F2895.
5.2 Radiography of cobalt- or iron-base surgical implant castings may create radiographic images resulting from grain
diffraction. Radiographic techniques shall be utilized to ensure differentiation between these images and actual indications.
5.2.1 Generally, cobalt- or iron-base surgical implant castings require radiation intensities higher than normal, facilitating
reduced exposure times.
1
5.2.1.1 Energies between 250 and 400 kV may be required to radiograph surgical implants with a ⁄2-in. (12.7-mm
...